US Food and Drug Administration (FDA) - Inactive Ingredients

FDA Inactive Ingredients - Updated May 2006

What is the purpose of the Inactive Ingredients Database?

The Inactive Ingredients Database provides information on
inactive ingredients present in FDA-approved drug products.
This information can be used by industry as an aid in developing drug products.
For new drug development purposes, once an inactive ingredient has appeared in an
approved drug product for a particular route of administration, the inactive ingredient
is not considered new and may require a less extensive review the next time it is included
in a new drug product. For example, if a particular inactive ingredient has been approved
in a certain dosage form at a certain potency, a sponsor could consider it safe for use in
a similar manner for a similar type of product.